We’re experiencing issues for some mobile devices with our ARTG dataset filter function. We apologise for any inconvenience while we work to fix this.
Applications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.
For further information see:
- Extension of indications to align with a reference product in Variations to prescription medicines: excluding variations requiring evaluation of clinical or bioequivalence data (for chemical entities).
- Extension of indications to align with a reference product in Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: process guidance.